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U.S. Department of Health and Human Services

Class 2 Device Recall EasyRA Cuvette Segments for EasyRA Clinical Chemistry Analyzer

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  Class 2 Device Recall EasyRA Cuvette Segments for EasyRA Clinical Chemistry Analyzer see related information
Date Initiated by Firm March 29, 2010
Date Posted October 18, 2010
Recall Status1 Terminated 3 on June 07, 2011
Recall Number Z-0078-2011
Recall Event ID 55150
510(K)Number K072249  K070057  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product EasyRA Cuvette Segment 1, P/N 007000-001
(In Vitro Diagnostic )
EasyRA Cuvette Segments included in the following Kits:
EasyRA Cuvettes, REF 10700-4
Startup Kit - Chemistry, REF 10990
Startup Kit - Chemistry & ISE, REF 10991
Code Information Lot Numbers:  2009/A2810, 2009/A2910, 2009/A3010, 2010/A2001, 2010/A21 01, 2010/A1901, 2009/A0211, 2009/A0311
Recalling Firm/
Manufacturer		 Medica Corporation
5 Oak Park Dr
Bedford MA 01730
For Additional Information Contact Photios Makris
781-275-4892
Manufacturer Reason
for Recall		 Chemistry analyzers may report Calcium results below the sample's actual concentration. Reported results may be ten to fifteen percent lower than expected sample results. The defect is a shortened path length at specific cuvette positions of those segments manufactured using molding cavity 1. The shortened path length was determined by measuring the cuvette dimensions with a Co-ordinate Measuri
FDA Determined
Cause 2		 Other
Action Medica issued an Urgent Product Recall letter dated March 29, 2010 to customers. Users were requested to cease using and discard the affected product, and complete and return a Response Form in order to obtain replacement product. Customers can contact Medica Technical Support at 877-777-5895.
Quantity in Commerce 14,926
Distribution Worldwide Distribution: USA, and the countries of Bulgaria, Canada, India, Mexico, Panama, Phillipines, Russia, Turkey, New Zealand, South Africa, United Arab Emirates, and Venezuela.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = MEDICA CORP.
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